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PIC/S Complaints, Quality Defects, Recalls & CAPA

PIC/S GMP principles for pharmaceutical complaints, quality defects, product recalls, investigations, CAPA, trending, management oversight and inspection readiness.

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Course Content

Module 1: Complaints & Quality Defects
  • 1. Pharmaceutical Complaints
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  • 2. Quality Defects
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Module 2: Complaint Management
  • 1. Complaint Handling Process
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  • 2. Complaint Investigation
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Module 3: Quality Defect Investigation
  • 1. Assessing the Quality Defect
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  • 2. Root Cause Overview
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Module 4: Product Recall
  • 1. Understanding Product Recall
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  • 2. Recall Process
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Module 5: CAPA & Preventing Recurrence
  • 1. CAPA Fundamentals
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  • 2. CAPA Effectiveness
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Module 6: Trending, Management Oversight & Inspection Readiness
  • 1. Trending and Management Review
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  • 2. Inspection Readiness
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Final Assessment
Complete all modules to unlock final exam
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